FDA 510(k) Application Details - K231165

Device Classification Name	Syringe, Antistick   More FDA Info for this Device
510(K) Number	K231165
Device Name	Syringe, Antistick
Applicant	Shina Med Corporation 455-30. Bogaewonsam-ro, Anseong-si, Gyeonggi-do, Republic of Korea Anseong-si 17509 KR Other 510(k) Applications for this Company
Contact	Tae Joo Ha Other 510(k) Applications for this Contact
Regulation Number	880.5860   More FDA Info for this Regulation Number
Classification Product Code	MEG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/25/2023
Decision Date	10/27/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review